BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 22GA X 1,00IN; INTRAVASCULAR CATHETER
|
Back to Search Results |
|
Catalog Number 38833514 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/10/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used as a default multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1131061.Medical device expiration date: 2026-04-30.Device manufacture date: 2021-05-26.Medical device lot #: 1119917.Medical device expiration date: 2026-04-30.Device manufacture date: 2021-05-13.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that 2 angiocaths 22ga x 1,00in had a needle through the catheter.The following information was provided by the initial reporter: " the deviations are catheter folded and needle through catheter.".
|
|
Event Description
|
It was reported that 2 angiocaths 22ga x 1,00in had a needle through the catheter.The following information was provided by the initial reporter: " the deviations are catheter folded and needle through catheter.".
|
|
Manufacturer Narrative
|
H6: investigation summary.A physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1131061, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the needle had pierced through the catheter tubing causing the tubing to appear bent.Based off the provided photo the engineer was able to verify the reported defect.However, the device appeared to have been used indicating that the device was not received in this condition.If the needle had already pierced through the catheter tubing the needle would not have been able to thread the catheter into the patient's vein.Therefore, the failure was most likely not a manufacturing defect.
|
|
Search Alerts/Recalls
|
|
|